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tor that can generate further interventions, as noted in Chapter 1. It should be kept in mind with respect to the following discussion that implants, surgical experience, surgical techniques, and perhaps other factors have evolved since the studies reported here were undertaken, so current experience may differ. This argues for careful prospective studies as the committee concludes at the end of this section.

This chapter addresses the following topics because they have significant effects on implant safety: reoperation or secondary procedures as indicators of overall frequency of local and perioperative complications; aggregate complications in breast reconstruction; aggregate complications in breast augmentation; rupture and deflation; factors contributing to loss of implant shell integrity; detection of gel implant rupture; strength and durability of implant shells; frequency of implant rupture and deflation; description of implant fibrous tissue capsules and contractures; capsular, local breast, and distant tissue exposures to silicone and their complications; frequency of saline implant capsular contracture; barrier implants and contractures; effect of implant surface and contracture; effect of local adrenal steroids and contracture; presence of bacteria around implants, antimicrobial treatment and contracture or other complications; hematomas, their frequency and relationship to contractures; the effect of implant placement on contracture; and other relevant complications including pain.

Many other local and perioperative complications in addition to those noted above require explantation or other secondary surgical or medical interventions. A reasonably complete list (see Table 5-1) would include fibrous contracture of the implant capsule; gel implant rupture (with or without migration of silicone gel outside the capsule) or saline implant deflation; filler port or implant valve malfunction; shell folds or wrinkling; infection of the surgical wound; infection around or within the implant; infection associated with toxic shock syndrome; hemorrhage and hematoma; seroma; swelling of the breast; various skin rashes and other skin manifestations such as localized morphea; epidermal proliferative reactions (Spiers et al., 1994); middermal elastolysis; edema; blistering; cysts (Copeland et al., 1993); ulceration; necrosis of the skin, nipple or mastectomy or reconstruction flap; exudation of silicone through the skin or from the nipple (Erdmann et al., 1992; Leibman et al., 1992; McKinney et al., 1987); implant extrusion, misplacement, or displacement; silicone granuloma; axillary adenopathy; sensory loss and paresthesia; pain; abnormal lactation (Hartley and Schatten, 1971; Mason, 1991) and/or galactocele (DeLoach et al., 1994; Johnson and Hanson, 1996); thoracic skeletal asymmetries (Dickson and Sharpe, 1987; Peters and McEwan, 1993); pneumothorax (Brandt et al., 1984); and calcification. "Bleed" or diffusion of small quantities of mostly lower molecular weight linear (and cyclic) silicone gel fluid compounds through the silicone elastomer shell (and to a



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